UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021830
Receipt number R000025169
Scientific Title Diagnosis of pulmonary lymphoma with BALF using molecular biological technique.
Date of disclosure of the study information 2016/04/07
Last modified on 2022/04/12 22:24:07

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Basic information

Public title

Diagnosis of pulmonary lymphoma with BALF using molecular biological technique.

Acronym

Diagnosis of pulmonary lymphoma with BALF.

Scientific Title

Diagnosis of pulmonary lymphoma with BALF using molecular biological technique.

Scientific Title:Acronym

Diagnosis of pulmonary lymphoma with BALF.

Region

Japan


Condition

Condition

Pulmonary lymphoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Establishmet of diagnositic method of pulmonary lymphoma using BALF with molecular biological technique

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Sensitivity and Specificity of an assessment of BALF with molecular biological technique for pulmonary lymphoma.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Suspiscious of pulmonary lymphoma, and showing pulmonary infiltration in radiological examination, and will be recieved BAL for diagnosis.

2. Patients who are obtained with the prior written informed consent.

Key exclusion criteria

1. Cases who are judged unsuitableness by attending doctors.
2. Cases who can not be recieved bronchoscopic examination in safety.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Kido

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code

8078555

Address

1-1, Iseigaoka, Yahatanishiku, Kitakyushu City, Fukuoka 807-8555, Japan

TEL

0936917453

Email

t-kido@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Kido

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code

8078555

Address

1-1, Iseigaoka, Yahatanishiku, Kitakyushu City, Fukuoka 807-8555, Japan

TEL

0936917453

Homepage URL


Email

t-kido@med.uoeh-u.ac.jp


Sponsor or person

Institute

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Neurology,Respirology,Endocrinology and Metabolism. Department of Internal Medicine, Faculty of Medicine,University of Miyazaki Hospital.
Second Department of Internal Medicine, Nagasaki University Hospital.
Department of Respiratory Medicine, Fukuoka University.
Department of Respiratory Medicine, Wakamatsu Hospital of University of Occupational and Environmental Health, Japan.
Department of Respiratory Medicine, Kokura Memorial Hospital.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Occupational and Environmental Health, Japan

Address

Iseigaoka, Yahatanishiku, Kitakyushu City, Fukuoka 807-8555, Japan

Tel

0936917453

Email

t-kido@med.uoeh-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

産業医科大学病院呼吸器内科(福岡県)
福岡大学病院呼吸器内科(福岡県)
長崎大学病院第2内科(長崎県)
宮崎大学病院第3内科(宮崎県)
産業医科大学若松病院(福岡県)
小倉記念病院(福岡県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

doi: 10.1038/s41598-021-02861-4

Number of participants that the trial has enrolled

39

Results

IGH rearrangement detection for B-cell lymphoma diagnosis exhibited sensitivity and specificity of 88.9% and 90.0%, respectively. TCR rearrangements were not observed in patients with B-cell lymphomas. The presence of IGH rearrangements together with the absence of TCR rearrangements indicated 96.0% specificity for the diagnosis of B-cell lymphoma. The sensitivity and specificity of MALT1 translocations for diagnosing MALT lymphoma were 28.6% and 100%, respectively.

Results date posted

2022 Year 04 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 12 Month 06 Day

Baseline Characteristics

Patients suspected of having pulmonary lymphoma by attending physicians based on their clinical history, laboratory data, and chest high-resolution CT (HRCT) results and admitted to our hospitals between October 2013 to March 2018 were enrolled.

Participant flow


Adverse events

None.

Outcome measures

In this study, we analyzed the feasibility of using BALF for combined detection of lymphocyte clonality based on IGH and TCR rearrangements as well as MALT1 translocations to diagnose pulmonary lymphomas.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 08 Month 27 Day

Date of IRB

2015 Year 08 Month 27 Day

Anticipated trial start date

2015 Year 08 Month 27 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To know the diagnostic value of an assessment of BALF with molecular biological technique for pulmonary lymphoma.


Management information

Registered date

2016 Year 04 Month 07 Day

Last modified on

2022 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name